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Pointe-Claire

    Gestionnaire, Cycle de Vie des Produits- Product Lifecycle Manager - Pointe-Claire, Canada - Medicomp Inc

    Medicomp Inc
    Medicomp Inc Pointe-Claire, Canada

    Found in: Talent CA C2 - 5 days ago

    Default job background
    Permanent
    Description

    Pourquoi se joindre à notre équipe ?

    Medicom est une entreprise bien établie, en pleine croissance, qui offre un environnement de travail stimulant. Nous recherchons des talents exceptionnels pour rejoindre notre équipe de gestion du cycle de vie des produits dans ce rôle d'envergure internationale. Nous offrons un salaire compétitif, un programme d'assurance complet, un régime de retraite et la possibilité d'un horaire de travail hybride.

    Note : L'utilisation du genre masculin a été adoptée afin de faciliter la lecture et n'a aucune intention discriminatoire.

    L'opportunité

    En tant que gestionnaire du cycle de vie des produits, vous aurez la responsabilité stratégique et tactique globale des projets qui faciliteront la réalisation de la commercialisation des produits de Medicom et des objectifs commerciaux généraux.

    Sous la responsabilité du directeur des affaires réglementaires et en étroite collaboration avec les parties prenantes des sites de production et des partenaires commerciaux de Medicom, vous jouerez un rôle essentiel dans la gestion du cycle de vie des dispositifs médicaux existant dans le portefeuille de Medicom. Cela comprend l'évaluation des opportunités et la fourniture de solutions de produits rentables, en mettant l'accent sur l'amélioration des produits existants, afin d'assurer la continuité des revenus, et sur le développement d'une nouvelle gamme de produits.

    Si vous avez de l'expérience dans la gestion de projets, dans la coordination de multiples tâches et projets parallèles, si vous avez une excellente compréhension et une bonne application du développement de dispositifs médicaux, du contrôle de la conception et des principes de gestion des risques, le tout associé à un état d'esprit d'amélioration continue et à un solide sens des affaires, nous aimerions vous entendre.

    Ce que vous apporterez

  • Licence en ingénierie, sciences de la vie, qualité/réglementation ou dans une discipline technique connexe.
  • Au moins 5 ans d'expérience professionnelle dans le domaine du cycle de vie et du maintien des produits, du développement de produits, de la gestion de projets et/ou de la recherche et du développement de dispositifs médicaux.
  • Compréhension avérée des réglementations américaines et canadiennes applicables et de la conformité des dispositifs médicaux.
  • Bonnes aptitudes à la communication orale et écrite ainsi que de solides compétences en matière de gestion de projet
  • Bilingue anglais-français

    • Un atout :

  • Maîtrise et/ou certification professionnelle dans une discipline technique liée à la science ou à l'ingénierie
  • Certification Six Sigma Green Belt, certification professionnelle en gestion de projet/produit
  • Compréhension des réglementations européennes applicables et de la conformité des dispositifs médicaux

    • Ce que vous ferez

    Stratégie/axe commercial

  • Élaborer une stratégie de cycle de vie des produits ainsi qu'un plan tactique pour préserver la santé et améliorer les produits existants afin d'assurer la continuité des revenues,
  • Permettre l'exécution, conforme, efficace et fondée sur les risques, du développement de produits/des plans de conception.
  • Créer et maintenir des spécifications techniques de production pour répondre aux exigences réglementaires et aux besoins des clients,
  • Se tenir informé et évaluer l'impact des changements de réglementation et accompagner les équipes marketing et commerciales dans leurs objectifs de revenus globaux,
  • Collaborer avec la direction pour déterminer le modèle opérationnel, le déploiement de la stratégie et les procédures de gouvernance.

    • Focus opérationnel/conformité

  • Veiller à ce que toute la documentation soit élaborée conformément aux normes réglementaires dans le cadre du cycle de vie du produit, et ce selon les procédures opérationnelles normalisées de contrôle de la conception et de contrôle des modifications,
  • Fournir un soutien technique et scientifique aux clients internes ainsi qu'un soutien technique aux activités d'approvisionnement et de fabrication au niveau mondial.
  • Négocier avec des sociétés de conseil externes pour le développement et les essais,
  • Veiller à ce que le département soit toujours prêt pour les audits réglementaires et soutenir les inspections et les audits de la documentation relative au contrôle de la conception.

    • Égalité des chances

    Medicom est un employeur qui souscrit au principe de l'égalité des chances. Nous examinons tous les candidats sans tenir compte de l'âge, du sexe, de l'identité ou de l'expression sexuelle, de l'orientation sexuelle, de la race, de l'origine ethnique ou nationale, des croyances religieuses, du sexe (y compris la grossesse et l'allaitement), du handicap ou de l'état matrimonial ou familial. Nous acceptons les candidatures de toutes les personnes qualifiées et encourageons les autochtones, les personnes de couleur, les personnes LGBTQ+ et les personnes non conformes au genre, les personnes handicapées, les femmes et les membres de tout autre groupe marginalisé à poser leur candidature. Faites passer votre carrière au niveau supérieur chez Medicom

    ***

    Why join our team?

    Medicom is a well-established, fast-growing company that offers a stimulating work environment. We are looking for exceptional talent to join our Product Lifecycle Management team in this role of international scope. We offer a competitive salary, a comprehensive insurance program, a pension plan, and the possibility of a hybrid work schedule.

    Note: the use of the masculine gender has been adopted to facilitate reading and has no discriminatory intent.

    The Opportunity

    As Product Lifecycle Manager you will have the overall strategic and tactical responsibility of projects that will facilitate the achievement of Medicom's product commercialization and overall business objectives.

    Reporting to the Director Regulatory Affairs and working closely with stakeholders across Medicom's manufacturing sites and commercial partners, you will play a critical role in the lifecycle management of medical devices existing in Medicom's portfolio. This includes scoping opportunities, assessing portfolio gaps and delivering cost-efficient product solutions with a focus on enhancing existing products, to ensure revenue continuity, and on the development of new line extensions.

    If you have experience in project management, in the coordination of multiple parallel tasks and projects, if you have a excellent comprehension and application of medical device product development, of design control and risk management principles, all coupled with a continuous improvement mindset and solid business acumen, we'd like to hear from you.

    What you will bring

  • Bachelor's Degree in engineering, life sciences, quality/regulatory or related technical discipline
  • Minimum of 5 years of related work experience in product lifecycle/sustainment, product development, project management and/or R&D of medical devices
  • Demonstrated understanding of applicable US and Canadian regulations and compliance for medical devices
  • Good oral and written communication skills and strong project management skills
  • Bilingual in English and French.

    • As an asset:

  • Master's degree and/or professional certification in scientific, engineering related technical discipline
  • Six Sigma Green Belt certification, project/product management professional certification
  • Understanding of applicable EU regulations and compliance for medical devices

    • What you will do

    Strategy/business focus

  • Develop product lifecycle strategy and tactical plan to maintain health and enhance existing products to ensure revenue continuity,
  • Enable compliant, efficient and risk-based execution of scaled phase-gate product development/design plans,
  • Create and maintain technical production specifications to meet regulatory requirements and customer needs,
  • Keep informed and assess impacts of changes in regulations and accompany marketing and commercial teams in their overall revenue objectives,
  • Collaborate with management in determining operating model, strategy deployment and governance procedures.

    • Operational/Compliance focus

  • Ensure that all documentation development is done as per regulatory standard within the product lifecycle according to design control and change control standard operating procedures,
  • Provide technical and scientific support to internal customers as well as technical support for global sourcing and manufacturing activities,
  • Negotiate with external consulting firms for development and testing,
  • Ensure continuous departmental regulatory readiness for audits and support inspections and audits of design control documentation.

    • Equal Opportunity

    Employer Medicom is an equal opportunity employer. We consider all applicants without regard to age, gender, gender identity or expression, sexual orientation, race, ethnic or national origin, religious beliefs, sex (including pregnancy and breastfeeding), disability or marital or family status. We welcome applications from all qualified individuals and encourage Indigenous persons, persons of color, LGBTQ+ and gender-nonconforming persons, persons with disabilities, women, and members of any other marginalized group. Take your career to the next level at Medicom

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